Status:
COMPLETED
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Adult T-cell Leukemia-Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The...
Eligibility Criteria
Inclusion
- Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
- Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
- Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
- Subjects who have been positive for CCR4 by CCR4 expression analysis
- Subjects who have never been treated for adult T-cell leukemia-lymphoma
- Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
- Subjects with a performance status of 0 to 2
- Subjects who have been negative for HBs antigen and anti-HCV antibody
- Subjects who have given written voluntary informed consent to participate in the study
Exclusion
- Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
- Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
- Subjects who have been positive for anti-HIV antibody
- Subjects with active multiple cancer
- Subjects with a history of allergic reactions to therapeutic antibodies
- Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses or who may require such radiotherapy after the start of the study
- Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01173887
Start Date
July 1 2010
End Date
April 1 2012
Last Update
March 30 2017
Active Locations (19)
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1
Fukuoka University Hospital
Fukuoka, Japan
2
Kyushu University Hospital
Fukuoka, Japan
3
National Kyushu Cancer Center
Fukuoka, Japan
4
Imamura Bun-in Hospital
Kagoshima, Japan